4/30/2015

Commercializing a medical device is always a challenge. But with the right knowledge, you can mitigate project risk and ease the path to regulatory approval.

On May 19 and 21, QNX will host info
days in Cambridge and Paris.

For almost 30 years, QNX Software Systems has been helping its customers build dialysis machines, infusion pumps, angiography systems, CT scanners, surgical robots, heart defibrillators, and a host of other medical devices. Moreover, we have built an OS that complies with international standards like IEC 62304 (medical device software) and IEC 61508 (functional safety systems). In the process, we’ve learned a thing or two about medical devices and how their software must specified, designed, developed, and maintained.

Which brings me to the medical information days that QNX will host this coming month in Cambridge and Paris. In both events, industry experts like Rob Higgins (head of regulatory affairs at MHRA, the agency that regulates medical devices in the UK) and Florence Collé (regulatory affairs manager at SNITEM, the national association of medical device manufacturers in France) will address regulatory and commercial challenges faced by today’s medical device manufacturers. Experts from IHS and, of course, QNX will also be on hand to deliver presentations and share their insights. Topics covered will include: